Identity
- Trade Name
- DenTASTIC® - Refill Kit FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- 6 ML EACH DENTASTIC ADHESIVE PRIMER PARTS A,B,C 6 ML EACH UNFILLED RESIN BONDING AGENT PARTS 1 AND 2 5 ML ETCH ALL, 10% PHOSPHORIC ACID ETCH GEL FDA UDI
- Model / Reference
- DASC1 FDA UDI
- Description
- 6 ML EACH DENTASTIC ADHESIVE PRIMER PARTS A,B,C 6 ML EACH UNFILLED RESIN BONDING AGENT PARTS 1 AND 2 5 ML ETCH ALL, 10% PHOSPHORIC ACID ETCH GEL FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701DASC12 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dentine bonding agent/set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DenTASTIC® - Refill Kit by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA UDI e95a1469-9152-4ca1-8c87-a0bf8136b6aa 34 fields · synced Jun 9, 2026